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Post by awesomo on Jan 20, 2022 17:54:53 GMT -5
So 2 months review instead of 6 months review, market treating this good news as if we're not going to get approval or are they trying to shake the tree for weak hands before for the sp goes up? Anyone? IMO neither. The market is very weak now for speculative companies. The market is in a wait and see mode for both approval as well as any potential revenue stemming from it. |
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Post by hellodolly on Jan 21, 2022 7:36:10 GMT -5
So 2 months review instead of 6 months review, market treating this good news as if we're not going to get approval or are they trying to shake the tree for weak hands before for the sp goes up? Anyone? IMO neither. The market is very weak now for speculative companies. The market is in a wait and see mode for both approval as well as any potential revenue stemming from it. Agreed, we may see a small pop on final approval, but until actual revenue is booked WS will wait to put in a valuation. Once that happens we'll see more analyst coverage and their new price targets and recommendations. Until then, like you said, 'wait and see mode'. |
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Post by Clement on Jan 21, 2022 8:48:09 GMT -5
UTHR is ready to rock and roll with Tyvaso DPI at the final approval in February. UTHR already has a) patients to be converted over to DPI very rapidly, b) DPI inventory, and c) staff (personnel) for this event.
"wait and see" ===> 1st and 2nd Q earnings calls
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Post by stockwhisperer on Jan 23, 2022 0:23:21 GMT -5
I thought the FDA had 150 to 180 days to make a final decision on the Citizens Petition. It was filed in early July, yet the FDA waited all this time and just sent Lassman a preliminary response the end of Dec - Jan 4, 2022, stating they are unable to make a final decision due to the complexity of the issues that require extensive investigation & analysis. What does that even mean. They should have made a decision by now - what is so complex about it - 180 days from July 8 was Jan 8. So frustrating. Just hope approval is in early February and the petition is denied - closed. downloads.regulations.gov/FDA-2021-P-0714-0007/attachment_1.pdf |
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Post by prcgorman2 on Jan 23, 2022 5:07:06 GMT -5
The “citzen’s petition” is an obvious legal maneuver and based on the FDA having issued a statement that essentially said they take a dim view of such efforts by competitors of products waiting to be approved, I assume the hurdles for the petitiion are very high. The FDA acknowledged a Class 1 review of the refile of the NDA for Tyvaso, and I don’t think the petition was mentioned in the CRL. I assume the petition will be seen for what it is and be denied, but I agree with the sentiment of wanting it denied and behind us.
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Post by boca1girl on Jan 23, 2022 10:02:36 GMT -5
The “citzen’s petition” is an obvious legal maneuver and based on the FDA having issued a statement that essentially said they take a dim view of such efforts by competitors of products waiting to be approved, I assume the hurdles for the petitiion are very high. The FDA acknowledged a Class 1 review of the refile of the NDA for Tyvaso, and I don’t think the petition was mentioned in the CRL. I assume the petition will be seen for what it is and be denied, but I agree with the sentiment of wanting it denied and behind us. I thought the CP was mentioned in the CRL. |
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Post by Chris-C on Jan 23, 2022 10:33:01 GMT -5
The “citzen’s petition” is an obvious legal maneuver and based on the FDA having issued a statement that essentially said they take a dim view of such efforts by competitors of products waiting to be approved, I assume the hurdles for the petitiion are very high. The FDA acknowledged a Class 1 review of the refile of the NDA for Tyvaso, and I don’t think the petition was mentioned in the CRL. I assume the petition will be seen for what it is and be denied, but I agree with the sentiment of wanting it denied and behind us. I thought the CP was mentioned in the CRL. The wording from the UTHR press release in October: "The complete response also notes, but does not cite as a deficiency, that the FDA has not yet completed its review of a Citizen's Petition submitted to FDA in July 2021 concerning the safety of an excipient in Tyvaso DPI." If one browses through the CP petitions on the FDA website, you begin to get a picture of what a jungle it is. Any citizen's advocate, professional, law firm, or consumer with an issue related to any matter under the jurisdiction of the FDA can send in a petition. Can you imagine how much taxpayer money is spent reading, reviewing, analyzing, corresponding and archiving this correspondence? Clearly, some of the filings are legitimate, but many of them actually serve as a thinly disguised means for obstructing, confusing, delaying, burdening and intimidating those in the regulatory process trying to serve the legitimate interests of consumers. Sometimes I think it's a miracle that any bureaucracy in this country is able to function at all. |
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Post by prcgorman2 on Jan 23, 2022 11:43:38 GMT -5
The “citzen’s petition” is an obvious legal maneuver and based on the FDA having issued a statement that essentially said they take a dim view of such efforts by competitors of products waiting to be approved, I assume the hurdles for the petitiion are very high. The FDA acknowledged a Class 1 review of the refile of the NDA for Tyvaso, and I don’t think the petition was mentioned in the CRL. I assume the petition will be seen for what it is and be denied, but I agree with the sentiment of wanting it denied and behind us. I thought the CP was mentioned in the CRL. I couldn’t remember for sure and was too tired to try and look for it. Thank you for keeping me straight bocagirl and Chris-C. |
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Post by mango on Jan 23, 2022 16:51:28 GMT -5
“One of the anticompetitive tactics we’ve been concerned with involves companies submitting certain types of citizen petitions in order to delay FDA action on a generic or other abbreviated application. While the FDA has rarely delayed specific drug approvals because of citizen petitions, there’s no doubt these shenanigans can burden the drug review process. Today we’ve issued a final version of a guidance for industry that addresses these concerns,” said FDA Acting Commissioner Ned Sharpless, M.D. “Also, to further dissuade companies from improperly using these petitions, the FDA will highlight in our annual report to Congress our determinations of petitions that are judged by the agency to have been submitted with the primary purpose of delaying an approval. Importantly, the guidance outlines our intention to refer these matters to the Federal Trade Commission, the agency that oversees anticompetitive business practices. We hope this increased transparency will help reduce hurdles to drug development and approval.” www.fda.gov/news-events/fda-brief/fda-brief-fda-issues-final-guidance-address-gaming-use-citizen-petitions |
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Post by stockwhisperer on Jan 23, 2022 19:32:39 GMT -5
That is great Mango but my concern is, why did it take the entire 180 days from the time the citizens petition was given to the FDA for the FDA to do no more than give a preliminary response - saying, that they have been unable to make a decision on the petition because it raises complex issues that require extensive review & analysis by agency officials. Those are strong words 180+ days later. Is this the customary type of response the FDA gives, months later, if they think the petition is inappropriate and should be dismissed. I have no idea. Just hope this petition is denied - closed and approval is granted early to mid Feb. Seems there always has to be something hanging out there. Political or otherwise, it sure gets tiring.
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Post by prcgorman2 on Jan 23, 2022 23:11:22 GMT -5
The regulatory attorneys that responded to the petition are not likely to be the same folks who are working the NDA. If I had to guess, there is more flexibility with regard to the response to the petition than there is to the NDA. The response to the NDA is governed by a law which sought to make the FDA more responsive and accountable. I’ll speculate the law said nothing about petitions. The regulatory agency I have the most familiarity with may not even respond to a petition. It simply goes on the record and becomes part of history. I don’t know how things will turn out but I am encouraged that the Street, at least, seems unconcerned.
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Post by sweedee79 on Jan 24, 2022 0:49:17 GMT -5
I was under the impression this CP issue had to be resolved before any approval could be granted.. that response doesn't sound like anything is resolved...
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Post by stockwhisperer on Jan 24, 2022 8:16:00 GMT -5
Here’s something about that… “unless the Secretary determines, upon reviewing the petition, that a delay is necessary to protect the public health. Thus, the FDA shall not delay approval of an ANDA, biosimilar, or repurposed drug application because of a petition unless the agency determines that the delay is necessary to protect the public health.” Nov 4, 2019
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Post by hellodolly on Jan 24, 2022 9:34:38 GMT -5
Here’s something about that… “unless the Secretary determines, upon reviewing the petition, that a delay is necessary to protect the public health. Thus, the FDA shall not delay approval of an ANDA, biosimilar, or repurposed drug application because of a petition unless the agency determines that the delay is necessary to protect the public health.” Nov 4, 2019 Not saying I'm on point here but if what you quoted is right, I don't think we have much to worry about in that regard. 1. This drug is already approved via a different delivery but with the same molecular profile that results in the same method of action for the patients that use it, in either delivery system (nebulizer vs powder), and 2. The harm is 'ultimately' more severe to those patients who will not have access to this drug immediately, in either the powder or nebulizer as those patients will likely die sooner, rather than later. Therefore, which is the greater harm? Delaying or approving? |
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Post by nylefty on Feb 25, 2022 20:28:18 GMT -5
My guess is approval June 27, 2022. 6 months from resubmission. My assumption is priority review still applies and thus 6 months. Also early summer as Martine stated. A reminder that it wasn't that long ago when we were thinking approval would come in "early Summer" or "June." Looking at it that way, May doesn't seem so disastrous. |
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